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510(k) Data Aggregation
(53 days)
NeedleCam HD Visualization System
NeedleCam HD™ Visualization System Indications for Use: The NeedleCam HD™ Visualization System is indicated to be used by a trained physician to provide illumination and visualization of an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures. Examples of surgical use include but are not limited to procedures on the knee, shoulder, ankle, elbow, wrist, temporomandibular joint (TMJ), spinal, ophthalmic, ENT, and the cervix.
NeedleCam HDTM Visualization System is comprised of an Image Capture Box, a Camera Handpiece (including an LED light source) that captures still images and full resolution video, and External Power Supply. The camera has a quick-release optical connector that adapts to a wide variety of Bio Vision Technologies' surgical endoscopes. The device is used with an endoscope to visualize and illuminate an interior cavity of the body through a natural or surgical opening in diagnostic and operative arthroscopic and endoscopic procedures.
The BioVision NeedleCam HD™ Visualization System submitted a Special 510(k) and did not conduct a study to prove the device meets acceptance criteria, but rather demonstrated substantial equivalence to a predicate device (BioVision SurgView™ Integrated Visualization System K082293) based on similarities in intended use, design, physical characteristics, and geometry, as well as modifications that are considered incremental changes and do not affect safety and effectiveness.
Here’s a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) or a direct comparison of such metrics against predefined thresholds. Instead, it relies on a comparison of technological characteristics to a predicate device, arguing that the new device is "substantially equivalent."
The table below summarizes the key comparisons made between the applicant device (NeedleCam HD™ Visualization System) and the predicate device (SurgView™ Visualization System K082293), highlighting similarities and differences. The implied "acceptance criteria" here are that the new device's characteristics are either identical or demonstrably equivalent/improved without compromising safety and effectiveness.
| Feature | Predicate Device (SurgView™ Visualization System K082293) | Applicant Device (NeedleCam HD™ Visualization System) | Comparison / Implied Performance |
|---|---|---|---|
| I. GENERAL CHARACTERISTICS | |||
| Device Description | Video endoscope/arthroscope imaging system with Light Source/Display/Image Capture device (internal monitor, image processor, Xenon light source, internal power supply), Camera handpiece, Semi-rigid Fiberoptic Scope, Media Capture CF Card System, Video output. | Video endoscope/arthroscope imaging system with Image Capture Box (image processor, external power supply), Camera handpiece (with LED light source), Semi-rigid Fiberoptic Scope, Media Capture USB System, Video Outputs. | Similar core function, updated components. |
| Intended Use | Illumination and visualization of interior body cavities in diagnostic and operative arthroscopic/endoscopic procedures (e.g., knee, shoulder, ankle, elbow, wrist, TMJ, spinal, ophthalmic, ENT, cervix). | Identical: Illumination and visualization of interior body cavities in diagnostic and operative arthroscopic/endoscopic procedures (e.g., knee, shoulder, ankle, elbow, wrist, shoulder, TMJ, spinal, ophthalmic, ENT, cervix). | Identical |
| Materials Used | Plastic enclosure, metal plate, media capture board, plastic camera cable, fiber optic cable. Scopes & instruments: Stainless Steel for Scope Shaft; Fiber Optics for light transmission. | Plastic enclosure, media capture board, plastic camera cable. Scopes & instruments: Stainless Steel for Scope Shaft; Fiber Optics for light transmission. | Similar, minor difference in enclosure description. |
| Labeling (Single Use/Reusable) | Image capture box and camera handpiece: Reusable. Scopes & instruments: Sterile, Single Use. | Identical: Image capture box and camera handpiece: Reusable. Scopes & instruments: Sterile, Single Use. | Identical |
| Image acquisition | Endoscope attached to a camera handpiece. Endoscope in sterile field, handpiece non-sterile with barrier. | Identical: Endoscope attached to a camera handpiece. Endoscope in sterile field, handpiece non-sterile with barrier. | Identical |
| Connectivity | Endoscope, camera handpiece, cable, illumination source, image processor connections; safe and reliable. Endoscope to camera handpiece via quick release. Fiberoptic bundle integrated with camera cable. Camera cable to light source/image capture with single hybrid (electrical/optical) connector. | Endoscope, camera handpiece, cable, illumination source, image processor connections; safe and reliable. Endoscope to camera handpiece via quick release. LED light source in camera handpiece. Camera cable to image capture device with single electrical connector. | Similar function, updated light source integration. |
| Image processing | Digitally processed for manipulation, capture, printing, multiple displays. | Identical: Digitally processed for manipulation, capture, printing, multiple displays. | Identical |
| Image display | Internal monitor display with external monitor connection. | External monitor connection. | Difference: no internal monitor, relies on external. |
| Data Entry | Session information entered via external keyboard. | Identical: Session information entered via external keyboard. | Identical |
| Data storage | Image and video storage to Compact Flash™ cards. | Image and video storage to USB device. | Difference: updated storage medium (USB). |
| Where used | Hospital / Doctor's office. | Identical: Hospital / Doctor's office. | Identical |
| II. CHARACTERISTICS OF THE LIGHT SOURCE | |||
| Illumination | Fiberoptic bundle attached to endoscope. Xenon light source internal to image capture box. LED and Xenon usable light output is equivalent. | Internal LED light source, integral to camera handpiece. LED and Xenon usable light output is equivalent. | Similar output, different technology/location. |
| Type of light source | Xenon | LED | Difference: updated technology (LED). |
| Lamp power rating | 35W | 1W | Difference: lower power (LED efficiency). |
| Rated lamp life | 3,000 hours | 20,000 hours | Difference: significantly increased lamp life. |
| Luminous intensity at scope output | 4-6 lumens | Identical: 4-6 lumens | Identical |
| III. CHARACTERISTICS OF THE CAMERA | |||
| Camera sensor | ¼" CCD | Identical: ¼" CCD | Identical |
| Sensor resolution | 768(H) x 494(V) pixels | Identical: 768(H) x 494(V) pixels | Identical |
| Camera resolution | 480 lines, interlaced | Identical: 480 lines, interlaced | Identical |
| Camera sterility | Non sterile. Drape is used for sterile field preservation. | Identical: Non sterile. Drape is used for sterile field preservation. | Identical |
| Endoscope coupler | Built-in | Identical: Built-in | Identical |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical testing was not used to prove substantial equivalence." Therefore, there was no test set of clinical data, no sample size, and no data provenance relevant to clinical performance. The evaluation was primarily based on engineering and design comparisons.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical testing was performed, no ground truth was established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set was used.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a visualization system (hardware), not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device; there is no standalone algorithm performance to evaluate in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical test set requiring ground truth was used. Substantial equivalence was based on technological similarity to a legally marketed predicate device.
8. The sample size for the training set
Not applicable. No algorithm or machine learning component is described that would require a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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